Endoscopic Ultrasound Shear Wave Elastography: A Novel Tool for Fibrosis Screening in Patients With Elevated Body Mass Index and Suspected Non-Alcoholic Fatty Liver Disease or Steatohepatitis

What this Trial Is About

This research aims to evaluate the use of endoscopic ultrasound shear wave elastography (EUS-SWE) as a screening tool for liver fibrosis in patients with elevated body mass index (BMI) and non-alcoholic fatty liver disease (NAFLD). It compares EUS-SWE accuracy to other non-invasive methods like the FIB-4 score and Fibroscan. The study also seeks to establish optimal liver stiffness cutoffs for EUS-SWE in this group, referencing liver biopsy as the gold standard, since no standard cutoffs currently exist. Participants undergoing routine endoscopic ultrasound as part of their clinical care will have the shear wave elastography added, which takes an extra 2-3 minutes without added risk or radiation exposure. The device used is an FDA-approved linear EUS endoscope with SWE features. Liver biopsy samples are obtained either during the same session or within six months of the ultrasound. Data including demographics, lab results, elastography, and biopsy findings are collected prospectively. During the study, participants will undergo the endoscopic ultrasound with shear wave elastography. Researchers will gather clinical, imaging, and biopsy data to analyze EUS-SWE accuracy and determine stiffness cutoffs for fibrosis grading. The primary outcomes include assessing EUS-SWE accuracy compared to biopsy and establishing stiffness thresholds. The study follows participants up to six months, ensuring privacy and secure data management throughout the process.

Endoscopic Ultrasound Shear Wave Elastography in Patients With Non-alcoholic Fatty Liver Disease